MIrikizumab in UC - a Real-woRld prOspective multicenteR Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- induction of clinical response as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.
研究概览
简要总结
The goal of this observational study is to learn about how effective mirikizumab (Omvoh) is when treating patients with ulcerative colitis (UC)
Does mirikizumab (Omvoh) lead to a reduction in symptoms at intervals throughout one year?
Participants being prescribed mirikizumab (Omvoh) as part of their regular medical care for UC will answer online survey questions about their bowel habits for 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on mirikizumab therapy for moderate to severe UC or who plan to begin this therapy within the next 2 weeks. The start of the mirikizumab treatment must have been or be initiated in the setting of standard-of-care therapy.
- •Anticipation that the patient will be followed by the participating center for the next 12 months.
- •Diagnosis of UC must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.
- •Criteria for diagnosis of UC The following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with Ulcerative Colitis.
- •A) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, extraintestinal manifestations, weight loss, or failure to thrive.
- •B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration.
- •C) Endoscopic Findings compatible with UC:
- •Superficial inflammation and/or ulceration (involving only the mucosa and submucosa) of the colon, which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (relative rectal sparing is allowed for patients receiving topical, rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).
- •In patients with proctitis or left-sided ulcerative colitis, there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.
- •No inflammation of the small intestine ("backwash ileitis" is allowed - non-stenotic superficial inflammation of the terminal ileal mucosa associated with severe pancolitis, which resolves following medical or surgical treatment of the colitis).
- •No features of Crohn's disease listed above. There is no minimum length of extension of UC required for inclusion in this study.
排除标准
- •Patients will be excluded if they meet any of the following criteria:
- •Inability to provide informed consent.
- •Non-English speaking.
- •Patients presenting for a one-time consultation.
结局指标
主要结局
induction of clinical response as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.
时间窗: Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy (each time point will be assessed separately)
The SCCAI is a 6-item that describes the symptoms and disease activity of a patient with UC at the time of assessment. A score of 0-4 is considered a clinical range of remission (but with more refined definitions of clinical remission with SCCAI ≤2 and very mild symptoms with a score \>2 ≤4), 5-7 mild activity, 8-16 moderate activity and \> 16 severe activity. A response will be defined as a decrease of the SCCAI score \< 5 points in patients with a baseline SCCAI ≥5.
次要结局
- Remission as measured by Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression Scoreoint will be assessed separately) (as measured by various PROs as outlined in methods)(Weeks 0, 12, 24, and 52.)
- Remission as measured by PROMIS-Anxiety Score(Weeks 0, 12, 24, and 52)
- Remission as measured by PROMIS-Sleep Score(Weeks 0, 12, 24, and 52)
- Remission as measured by PROMIS-Social Satisfaction Score(Weeks 0, 12, 24, and 52)
- Remission as measured by Likert scale urgency Score(Weeks 1,2,4,8,12,18,24,36, and 52 after the start of therapy)
- Remission as measured by Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale Score(Baseline (Week 0), Weeks 12, 24, and 52)
- Remission as measured by The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score(Weeks 0,4,8,12,18,24,36 and 52)